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Clinical Trial Details

Trial ID: L2687
Source ID: NCT04271189
Associated Drug: Metformin-Sitagliptin-Empaglifozin-Pioglitazone
Title: Managing DIabetes Remission After Combined Therapy in EarLy Stage of DiabetEs
Acronym: MIRACLE
Status: COMPLETED
Study Results: NO
Results:
Conditions: Newly Diagnosed Type 2 Diabetes
Interventions: DRUG: Metformin-Sitagliptin-Empaglifozin-Pioglitazone|DRUG: Standard of care
Outcome Measures: Primary: Assess the T2DM remission rate in patients with newly diagnosed T2DM treated with either POLYCHEM or with SDC for 16 weeks., Remission was defined as HbA1c \<6.5% or 48mmol/mol for at least 12 weeks without pharmacologic or surgical treatment for diabetes., 12 weeks after the end of treatment | Secondary: Assess the proportion of complete T2DM remission rate in the 2 groups, Normal measures of glucose metabolism (fasting glucose and HbA1c in normal range), for at least 12weeks without pharmacologic or surgical treatment for diabetes., 12 weeks after the end of treatment|Monitor the quality of life EQ-5D-DL, Will be monitored through EQ-5D-DL questionnaires., 0, 16, 28 weeks|Monitor the quality of life ADDQOL, QoL will be monitored through ADDQOL questionnaires., 0, 16, 28 weeks|Monitor the costs of National Health System service utilization, All accesses to the National Healthcare System resources by each patient (visits, treatments, supplies, hospital admissions, etc.) will be retrieved from the Regional Health Registries and recorded. Costs will be assessed from a public purchaser perspective. For this reason all costs will refer to the reimbursement provided to the health facilities by the national health system., 0, 16, 28 weeks|Quantify the effects of either POLYCHEM or SDC on the main determinants of glucose regulation, In all patients C-peptide will be used to compute static surrogate indexes of insulin sensitivity and beta cell function., 0, 16, 28 weeks|Quantify the effects of either POLYCHEM or SDC on the main determinants of glucose regulation, In all patients insulin values will be used to compute static surrogate indexes of insulin sensitivity and beta cell function., 0, 16, 28 weeks|Quantify the effects of either POLYCHEM or SDC on the main determinants of glucose regulation, Glucagon values will provide indexes of alpha cell function and of gut K- and L-cell function. Their role in predicting and/or explaining T2DM remission and/or relapse will be assessed., 0, 16, 28 weeks|Quantify the effects of either POLYCHEM or SDC on the main determinants of glucose regulation, GLP-1 values will provide indexes of alpha cell function and of gut K- and L-cell function. Their role in predicting and/or explaining T2DM remission and/or relapse will be assessed., 0, 16, 28 weeks|Quantify the effects of either POLYCHEM or SDC on the main determinants of glucose regulation, GIP values will provide indexes of alpha cell function and of gut K- and L-cell function. Their role in predicting and/or explaining T2DM remission and/or relapse will be assessed., 0, 16, 28 weeks
Sponsor/Collaborators: Sponsor: Azienda Ospedaliero-Universitaria di Parma
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 108
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-09-01
Completion Date: 2024-12-31
Results First Posted:
Last Update Posted: 2025-03-18
Locations: Azienda Ospedaliero Universitaria di Parma, Parma, 43126, Italy
URL: https://clinicaltrials.gov/show/NCT04271189